Herbal Medicine Clinical Trial and Research Services, Including Thai Traditional Medicines

Herbal medicines are medicines in which herbs are the key ingredients, used to treat, relieve or prevent illness. They include Thai traditional medicines made to traditional formulas and developed herbal medicines, in the form of tablets, capsules, powders, oral liquids and decoctions, as well as medicines for external use such as herbal balms and plai cream. A herbal medicine clinical trial is a study in participants under controlled conditions that compares outcomes between a group receiving the test herbal medicine and a control group, such as a group receiving a placebo, to measure the efficacy and safety of the formula in actual use.

Thailand has accumulated knowledge of herbs and Thai traditional medicine over several centuries, and the domestic market for herbal medicines continues to grow, for both traditional formulas and formulas that have been modernized. Herbal and Thai traditional medicines, both oral and for external use, are governed by the Herbal Products Act B.E. 2562 (2019). Companies that want to communicate indications on labels or in marketing materials must therefore consider both the scope of indications authorized by the Thai Food and Drug Administration (Thai FDA) and the evidence that supports the statement. Conventional drugs whose active ingredient is extracted from herbs remain under the Drug Act B.E. 2510 (1967); these are covered by VISBIO’s clinical research services for topical drugs and oral OTC drugs.

VISBIO Co., Ltd. provides study design, project management and project coordination for clinical research on herbal and Thai traditional medicines, in collaboration with a network of partner clinical research sites and hospitals. The service covers protocol design, approval from the human research ethics committee, coordination of participant recruitment and data collection with the research site, statistical analysis and the complete scientific report, under the internationally referenced principles of Good Clinical Practice (GCP), for sponsors in Thailand and abroad.

Under the Herbal Products Act B.E. 2562 (2019), herbal products, including Thai traditional medicines and developed herbal medicines, must be notified, submitted for detailed notification or registered with the Thai FDA, according to the product’s risk level, before they are sold. For formulas that must be registered, the review covers quality, safety and the indications applied for. An authorized product may therefore state only the indications for which it was authorized.

Manufacturers that want to communicate specific effects of their herbal medicine on labels or in advertising, such as “helps relieve symptoms”, should have clinical data on their own formula to support these statements. Indication statements on labels and in advertising must stay within the authorized scope; to state additional indications, the Thai FDA’s procedures must be completed first, and advertising of herbal products requires Thai FDA permission before publication.

At the same time, herbal medicine markets in Thailand and abroad are placing more weight on evidence-based herbal medicine. Consumers and healthcare professionals have begun to question statements that are not backed by research, and some importers in overseas markets ask for clinical evidence before they accept products for sale.

Clinical research designed by VISBIO together with the investigators builds empirical evidence directly, by comparing outcomes on the target symptoms between a group receiving the test herbal medicine and a group receiving a placebo, under conditions controlled according to GCP. The data support product development and evidence-based communication.

Thai herbs contain many groups of active compounds that have been studied continuously at the basic science and cellular levels. The next step is to confirm their effects in humans. Bunmee et al. (2025) studied a Thai herbal blood lipid-lowering formulation in a double-blind multicenter randomized controlled trial in people with borderline hyperlipidemia over 12 weeks, using laboratory blood lipid values as the outcome measures. The same work also analyzed the chemical composition, antioxidant activity and cytotoxicity of the extract, showing that Thai herbal formulas can be evaluated clinically in a systematic way when the protocol is designed appropriately.

On research methodology, Koonrungsesomboon et al. (2024) analyzed 1,517 herbal medicine clinical trials published between 2019 and 2022 and found that the most common design was a randomized, double-blind, parallel-group trial with a 1:1 allocation ratio, with widespread use of placebo, and that capsules were the most common dosage form. VISBIO uses this overview with the investigators as a basis for choosing the study design, endpoints and participant group to match the claim for each formula.

The strength of herbal medicine clinical research lies in choosing endpoints that can actually be assessed clinically, such as assessment of target symptoms with standard tools, quality-of-life measures and monitoring of adverse events, designed to suit the indication under study and a participant group that can realistically be reached. For example, Tawanwongsri et al. (2025) studied Centella asiatica extract as a dietary supplement in a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes in Thailand for 6 months, with glycated hemoglobin (HbA1c) as the primary endpoint, together with other biochemical values and adverse event monitoring. The prespecified primary analysis found no difference between groups, and participants tolerated the product well. This example shows that a study designed with its analysis planned in advance gives a reliable answer, whichever way the results turn out.

Every research project follows GCP and takes into account the particular characteristics of herbal medicines and Thai traditional formulas, whose endpoints must be designed to match the indication under study. VISBIO designs the study and provides project management and coordination, while participant recruitment, clinical assessment and care are carried out by the physicians and investigators of the research site responsible for the study.

Step 1: Consultation and protocol design

Together with the investigators of the research site, VISBIO reviews the characteristics of the formula, the effects the sponsor wants to claim and the purpose of the product, in order to define a suitable study plan, including the choice of a primary endpoint that matches the indication of the herbal medicine. This step covers setting inclusion and exclusion criteria that fit the claim, and estimating a sample size with adequate statistical power.

Step 2: Ethics approval and planning for Thai FDA requirements

Before any data are collected, the protocol and the informed consent documents must in every case be approved by a human research ethics committee (Institutional Review Board: IRB). VISBIO coordinates document preparation with the investigators and follows up on revisions requested by the committee until approval is granted. At this stage, the sponsor, the research site and VISBIO also check the Thai FDA requirements that apply to the product used in the study and plan the necessary steps together from the start of the project.

Step 3: Participant recruitment and screening

Once approval is granted, the physicians and investigators of the research site responsible for the study recruit and screen volunteers or patients according to the criteria in the protocol. They make sure that every participant receives complete information, gives written consent and passes a health screening before joining the study. VISBIO coordinates schedules and study readiness between the sponsor and the research site.

Step 4: Study conduct and data collection

Participants receive the test herbal medicine or a placebo, and data are collected at the time points set in the protocol, using standard assessment tools accepted in clinical research, such as target symptom severity scales, daily symptom diaries, quality-of-life scales and product acceptance questionnaires, together with recording of adverse events throughout the study. The site’s physician investigators carry out the clinical assessments and look after participant safety, while VISBIO, as project manager, monitors progress and the completeness of the data.

Step 5: Data analysis and reporting

All data are analyzed statistically according to a statistical analysis plan (SAP) set in advance and summarized in a complete scientific report in an internationally used format. VISBIO coordinates the analysis and delivers the report to the sponsor. The report provides clinical data that support product development and evidence-based communication, subject to the legal conditions described in the section on herbal medicine authorization.

This service is designed for herbal medicines and Thai traditional formulas that need clinical data to support their claims. Examples of suitable product types and dosage forms are shown below.

Studies in people with symptoms of a specific disease are carried out at partner research sites or hospitals, where the physician investigators screen the patients, assess their symptoms and look after them throughout the study. For conventional topical drugs governed by the Drug Act B.E. 2510 (1967), see the topical drug clinical research service.

Data from clinical research are not just a regulatory burden. They are a strategic asset that owners of herbal medicine products can use to create value in several ways, while all communication must still comply with herbal products law.

Premium product positioning

Herbal medicines with clinical research data can be positioned in the premium segment on a sound basis. In a market where consumers have more and more access to health information, outcomes measured in the group receiving the test medicine, compared with a control group, help communicate value that sets the product apart from herbal medicines without such data.

Negotiations with pharmacies, modern trade and e-commerce

Many pharmacies, modern retailers and e-commerce platforms in the health and drug categories have begun to ask for supporting scientific documents. A clinical research report prepared under GCP makes negotiations and product listing in these channels smoother.

Lower legal risk and expansion into export markets

Indication statements supported by clinical data reduce the risk that advertising will be considered to overstate the product’s properties under the Herbal Products Act B.E. 2562 (2019), but they do not replace the step of obtaining advertising permission from the Thai FDA. For export markets, clinical data designed and reported to international practice are part of the documents used to prepare registration or negotiations with trading partners, especially in ASEAN and in markets interested in Thai herbal products, and each country has its own requirements.

Using scientific data in communication

Data actually measured in clinical research are empirical evidence that builds confidence among both consumers and healthcare professionals. Use in advertising requires Thai FDA permission before publication, and statements must stay within the authorized indications.

1. Herbal and Thai traditional medicines sold in Thailand must already be authorized by the Thai FDA under the Herbal Products Act B.E. 2562 (2019) (notification, detailed notification or registration, according to the product type). For products of sponsors from abroad, VISBIO assesses the legal conditions together with the research site on a project-by-project basis.
2. VISBIO and the research site design the study plan specifically for the indication and the claim of each formula.
3. Every study must be approved by a human research ethics committee before it starts, without exception.

For product owners who want evidence at every level, VISBIO supports work from quantitative analysis of key compounds in herbs, such as andrographolide in andrographis and curcuminoids in turmeric, and biological activity testing at the cellular level (In Vitro), such as anti-inflammatory activity, through to clinical research in humans. Laboratory results that show the mechanism of action can be used as a basis for choosing clinical research endpoints that are consistent with them, as in the work of Bunmee et al. (2025), which analyzed the chemical composition and activity of the extract in the laboratory alongside the clinical study. GCP applies to studies in humans, while laboratory work follows the test method for each assay.

Which law governs herbal medicines?

Herbal medicines, including Thai traditional medicines and developed herbal medicines, are governed by the Herbal Products Act B.E. 2562 (2019). They must be notified, submitted for detailed notification or registered with the Thai FDA, according to the product’s risk level, before they are sold, and advertising requires Thai FDA permission before publication. Conventional drugs whose active ingredient is extracted from herbs remain under the Drug Act B.E. 2510 (1967).

Why should an authorized herbal medicine still have clinical data?

What the Thai FDA reviews depends on the type of authorization. For formulas that must be registered, the review covers quality, safety and the indications applied for. Clinical data on your own formula help you communicate its effects with evidence within the scope of the authorized indications, and support negotiations with pharmacies, trading partners, importers and healthcare professionals.

How are herbal medicine clinical trials usually designed?

Most herbal medicine clinical trials published between 2019 and 2022 used a randomized, double-blind, parallel-group design with a 1:1 allocation ratio and widespread use of placebo (Koonrungsesomboon et al., 2024). The design actually chosen depends on the indication under study and the participant group.

Who looks after the participants, and what is VISBIO’s role?

The physicians and investigators of the partner research site responsible for the study recruit, assess and look after the participants. VISBIO designs the study and provides project management and coordination between the sponsor and the research site, from planning to delivery of the report.

Can research results be used in advertising right away?

Not immediately. Advertising statements must stay within the authorized indications, and advertising of herbal products requires Thai FDA permission before publication. Study results are supporting information, while the decision rests with the government authority. VISBIO does not guarantee study outcomes or such decisions.

What needs to be prepared before a project starts?

Herbal medicines sold in Thailand must already be authorized by the Thai FDA under the Herbal Products Act B.E. 2562 (2019). For products of sponsors from abroad, the legal conditions are assessed together with the research site on a project-by-project basis. The study plan is designed for the indication and the claim of each formula, and every project must be approved by a human research ethics committee before it starts.

If you are interested in clinical research for your herbal or Thai traditional medicine, contact VISBIO for a free initial consultation through any of these channels:

• Contact form: https://visbio.co.th/en/contact-us/
• LINE Official Account: @visbio
• Email: service@visbio.co.th
• Phone: 098-635-4197
• Timeline: please ask our team directly.

See all clinical trial services on VISBIO’s clinical trial service page.

• VISBIO’s role: VISBIO designs studies and provides project management and project coordination in collaboration with a network of partner clinical research sites and hospitals, for sponsors in Thailand and abroad. Volunteers are recruited and cared for by the physicians and investigators of the research site responsible for the study.
• Research ethics: Every study in humans starts only after approval by a human research ethics committee and is conducted under Good Clinical Practice (GCP). Every volunteer signs an informed consent form after receiving complete information.
• Drugs and herbal medicines: Studies must follow the Thai FDA requirements that apply to the product. The sponsor, the research site and VISBIO plan these steps together from the start of the project.
• Use of results: Study results support product development and evidence-based communication. Use on labels or in advertising must comply with the law for each product type, with approval from the relevant authorities where the law requires it. VISBIO does not guarantee study outcomes or regulatory decisions.
• Foods and dietary supplements: Study results are not a claim that a product diagnoses, treats, cures, mitigates or prevents any disease.
• Timeline: This depends on the study design and the approval process. Please ask our team directly.

References:

1. Bunmee, P., Subhadhirasakul, S., Niyomtham, N., & Siriyong, T. (2025). Clinical and biological efficacy of Thai herbal blood lipid-lowering formulation for borderline hyperlipidemia: A double-blind multicenter randomized controlled trial. Journal of Evidence-Based Integrative Medicine, 30, 2515690X251391671. https://doi.org/10.1177/2515690X251391671
2. Koonrungsesomboon, N., Sakuludomkan, C., Na Takuathung, M., Klinjan, P., Sawong, S., & Perera, P. K. (2024). Study design of herbal medicine clinical trials: A descriptive analysis of published studies investigating the effects of herbal medicinal products on human participants. BMC Complementary Medicine and Therapies, 24(1), 391. https://doi.org/10.1186/s12906-024-04697-7
3. Tawanwongsri, W., Mordmuang, A., Phenwan, T., & Siri-Archawawat, D. (2025). Efficacy and safety of Centella asiatica (L.) Urb. [Apiaceae] as a dietary supplement for glycemic control and lipid regulation in patients with type 2 diabetes: A randomized controlled trial in Thailand. Frontiers in Pharmacology, 16, 1680647. https://doi.org/10.3389/fphar.2025.1680647